K253188 is an FDA 510(k) clearance for the CoaguChek XS Plus System. This device is classified as a Test, Time, Prothrombin (Class II - Special Controls, product code GJS).
Submitted by Roche Diagnostics (Indianapolis, US). The FDA issued a Cleared decision on October 24, 2025, 28 days after receiving the submission on September 26, 2025.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.7750.
| 510(k) Number | K253188 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 26, 2025 |
| Decision Date | October 24, 2025 |
| Days to Decision | 28 days |
| Submission Type | Special |
| Review Panel | Hematology (HE) |
| Summary | Summary PDF |
| Product Code | GJS — Test, Time, Prothrombin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.7750 |